Overview of the FDA-Approved OraQuick® Rapid HIV-1 Antibody Test
IVD Roundtable Meeting February 7, 2003
Elliot P. Cowan, Ph.D.
Senior Regulatory Scientist
Office of Blood Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
[PowerPoint]
Rapid HIV Test Approval
- On November 7, 2002, FDA approved the OraQuick® Rapid HIV-1 Antibody Test
as a moderate complexity device under CLIA '88
- Intended use:
- To detect antibodies to HIV-1 in fingerstick whole blood specimens
- A point-of-care test to aid in the diagnosis of infection with HIV-1
- Suitable for use in multi-test algorithms designed for statistical validation
of rapid HIV test results
OraQuick® is Approved as a Restricted Device
- Sale is restricted to clinical laboratories
- that have an adequate quality assurance program, including planned systematic
activities to provide adequate confidence that requirements for quality
will be met; and
- where there is assurance that operators will receive and use the instructional
materials
- Approved for use only by an agent of a clinical laboratory
- Test subjects must receive the "Subject Information" pamphlet
prior to specimen collection and appropriate information when test results
are provided
- Not approved for use to screen blood or tissue donors
- Customer letter included with all kits
- "By purchasing this device, you are doing so as an agent of a clinical
laboratory and agree that you or any of your consignees will abide by the...restrictions
on the sale, distribution, and use of the device..."
Description of the OraQuick® Test
Description of the OraQuick® Test
Description of the OraQuick® Test
Description of the OraQuick® Test
Description of the OraQuick® Test
Description of the OraQuick® Test
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20-60
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Follow CDC guidelines to inform the test subject of the test
result and its interpretation.
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OraQuick® Results and Interpretation
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RESULT: NON-REACTIVE
INTERP: NEGATIVE
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OraQuick® Results and Interpretation
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RESULT: REACTIVE
INTERP: PRELIM POSITIVE
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OraQuick® Results and Interpretation
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IVALID TEST RESULTS
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OraQuick® Clinical Trial Data: Sensitivity
Group |
Total Samples |
OQ Reactive |
Licensed EIA RR |
WB+ |
| AIDS |
40 |
40 |
40 |
40 |
| Known HIV-1+ |
481 |
479 |
481 |
481 |
| High Risk |
625 |
17 |
20* |
17 |
| TOTAL |
1146 |
536 |
541 |
538 |
| *2 specimens negative
and 1 indeterminate by WB |
SENSITIVITY IN TRIAL: 99.6% (98.5%-99.9%) |
OraQuick® Clinical Trial Data: Specificity
Group |
Total Samples |
OQ
NR |
Licensed EIA NR |
True NEG |
| Low-Risk |
1250* |
1248 |
1247 |
1248 |
| High-Risk |
625 |
608 |
605 |
608 |
| TOTAL |
1875 |
1856 |
1852 |
1856 |
| *Two specimens from low-risk
study gave Reactive results with OQ, RR results with EIA, and postive results
with WB. |
SPECIFICITY IN TRIAL: 100% (99.7%-100%) |
OraQuick® Clinical Trial Data: Reproducibility
- 3 sites, 3 lots, 3 different days, 3 operators/site (9 total)
- Blind-coded panel of 5 contrived whole blood specimens
- 4 antibody-positive and 1 antibody-negative specimen
- 20-minute read time: 404/405 = 99.8%
- 55-60 minute read time: 405/405 = 100%
OraQuick® CLIA '88 Waiver
- OraQuick® was granted a CLIA '88 waiver on January 31, 2003
- Data submitted in support of waiver
- At 4 sites, 100 lay users with no laboratory experience tested panels
of 6 masked randomized specimens
- 2 negative, 2 low positive, 2 high positive
- No statistically significant difference between lay user results and correct
results
- Sales and use restrictions remain in place for the waived test
- Quality Assurance program recommendations for rapid HIV tests
are being developed by CDC
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